Volume-adjustable manual ventilation device

ABSTRACT

Disclosed is a manually operable volume-adjustable ventilation device. The device includes a reservoir with an inlet mechanism, an outlet mechanism, and a volume adjuster configured to move a volume adjustment limit of the reservoir and change an expressed maximum volume of the reservoir. The reservoir has a body having a plurality of movable walls defining an enclosed volume. The reservoir has an uncompressed state and a compressed state. The walls of the reservoir are movable with respect to each other, such that moving the walls expresses the volume adjustment limit of the reservoir. The walls can be operably connected by movable structures configured such that two adjacent walls are configured to rotate around substantially orthogonal axes with respect to each other when the reservoir moves from an uncompressed to a compressed state. In some embodiments, the movable structures can be hinges, such as snap-fit assembly hinges. Methods of ventilating a patient that involve the device are also disclosed.

REFERENCE TO RELATED APPLICATIONS

This is a continuation-in-part application that claims the benefit under35 U.S.C. §120 of U.S. patent application Ser. No. 11/147,070, filedJun. 6, 2005 now U.S. Pat. No. 7,537,008, which is hereby incorporatedby reference herein in its entirety.

FIELD OF THE INVENTION

The present invention relates generally to manual ventilation devices.

BACKGROUND OF THE INVENTION

Manual ventilation or resuscitation is performed on an individual whenthey are unable to breathe independently. Typically, this occurs when anindividual is transported from one section of a hospital to anothersection such as an emergency room and an intensive care unit, or in anambulance. Manual resuscitation also occurs during cardiopulmonaryresuscitation (CPR), which is a standard technique applied to victims ofcardiopulmonary arrest with the goal to re-establish normal cardiac andrespiratory function.

Ventilation from a manual resuscitation device is currently provided bya self-filling elastomeric enclosure or bag. This bag is compressible byhand, a face-fitting mask (or intubation tube) in fluid communicationwith an outlet passage of the bag, and a one-way valve between the maskand bag to permit only fluid passage from the bag to the mask. The bagalso has an inlet passage, typically with one opening for air andanother, usually smaller opening for receiving oxygen. By squeezing thebag with their hand(s), a clinician delivers air or oxygen to anindividual, and then releases the bag to permit it to expand to fullsize and thereby draw air or oxygen through the inlet passage.

The amount of air received by the lungs of the individual corresponds tothe volume of the bag. A larger bag provides a greater maximum volume ofair to be pumped into the individual. Children and infants typicallyhave smaller lungs than an adult, and therefore conventional manualresuscitation devices are provided in different sizes; e.g., infant,child and adult. Each size provides a different maximum volumetricoutput of air. Depending on factors such as physical condition, bodysize, age, sex, etc., each individual may require a specific volume ofair (tidal volume), and frequency, and minute ventilation.

Unfortunately, current manual ventilation or resuscitation devices arenot suitable for the desired monitoring and control of tidal volumedelivery. For instance, the collapsible bag portion of the resuscitationdevice allows the user to merely “feel” the amount of air they areproviding to the individual. This provides them merely a very roughestimate of the volume of air they are providing and a tactile feel forwhen the lungs are non-compliant, i.e. are being pressurized. Althoughself-filling respiration (resuscitation) enclosures or bags can beselected on the basis of known maximum volumes, the volume actuallydelivered can vary substantially among several operators, dependent uponfactors such as hand size, number of hands used, technique, enthusiasmand fatigue. These variations have been shown to be as much as 60percent of the optimal tidal volume. Frequency can also vary betweenusers, resulting in potential underventilation or overventilation.

Accordingly, what is needed is a single manual ventilation orresuscitation device that can be used on any patient, regardless ofindividual factors such as physical condition, body/lung size, age andsex.

SUMMARY OF THE INVENTION

In one aspect, disclosed is a ventilation device that includes areservoir having a movable wall defining an enclosed volume, such thatmoving the wall expresses an adjustment limit. Moving the limit resultsin a change in the expressed maximum volume of the device.

In another aspect, disclosed is a single manual ventilation orresuscitation device. The body of the device has panels, that can berigid, that encompass a sealed volume with an inlet mechanism and anoutlet mechanism. The rigid panels are movable with respect to eachother to allow the body to move between an uncompressed state and acompressed state. Once in compressed state a volume restoring mechanismis responsible to restore the volume from the compressed state back tothe uncompressed state.

One of the objectives of the invention is to be able to hold the bodywith one hand and to compress the body with that one hand. To meet thisobjective, in one embodiment, the body is characterized by having adisplacement in a direction of a hand displacement (e.g., height of thebody) and at least one other direction (e.g., width of the body) otherthan this hand displacement. In another embodiment, the body ischaracterized by having a displacement in a direction of a handdisplacement (e.g., height of the body) and at least two otherdirections (e.g., width and length of the body) other than this handdisplacement. The displacement in width and/or length is a function ofthe height displacement and the geometry of the rigid panels.

The axial displacement of a panel is preferably no more than about 85mm, preferably no more than about 20-25 mm, and more preferably no morethan about 10-15 mm. Some of the displacements would have to comfortablyfit between the thumb, one or more fingers and the web of the hand. Inother words, the natural range of a grasping motion of a hand definesthese displacements. The expressed (delivered) volume of the device, insome embodiments, can be no more than about 500 cc, or no more thanabout 250 cc (infant and child), or no more than about 1400 cc (infantto adult). In another embodiment, the expressed (delivered) volume ofthe device can range from about 250-1200 cc (child to adult).

A size adjuster is included to adjust one or more of the bodydisplacements to change the dimension of the uncompressed state orvolume. These axial size adjustments can be no more than about 170 mm,and preferably no more than about 25 mm in some embodiments. Theobjective of the size adjuster is to adjust the displacement to thenadjust the volume of e.g., the air delivered to an individual. Hence thesize adjuster is also referred to as a volume adjuster.

A frequency adjuster is included to adjust the time to restore thevolume from the compressed state to the uncompressed state or to adjustthe time to compress the volume from the uncompressed state to thecompressed state.

Feedback mechanisms could be included to provide tactile feedback,visual and/or audible feedback to the user. An example of tactilefeedback is to include tactile feedback areas, e.g., a flexiblematerial, to cover an opening in a rigid panel. These areas allow theuser to feel the compression force or lung resistance. These tactileareas are preferably sized and positioned to fit a thumb or one or morefingers of the user's hand. An example of a visual feedback mechanism isto provide the user feedback over the size (volume) adjustments or thefrequency. An example of an audible feedback mechanism is to provide theuser feedback over e.g., the compression speed, frequency, tidal volume,setting of the size (volume) adjuster or setting of the frequencycontrol adjuster.

One advantage of the device is the ergonomic fit of the body to a user'shand in both uncompressed and compressed state, which reduces fatigue tohand and/or arm muscles. Another advantage of the device is the abilityto adjust the volume and/or frequency so that the user can rely on amore or less constant tidal volume and tidal rate. Such ability allowsone to use the device on any patient, regardless of individual factorssuch as physical condition, body/lung size, age and sex. Yet anotheradvantage is that multiple devices could easily be stacked or nestedwith each other. In exemplary embodiments, the design and geometry couldbe configured to include such stacking or nesting capabilities.

In another aspect, disclosed is a manually operable volume-adjustableventilation device. The device has a reservoir with an inlet mechanism,an outlet mechanism, and a volume adjuster configured to move a volumeadjustment limit of the reservoir and change an expressed maximum volumeof the reservoir. The reservoir has a body having a plurality of movablewalls defining an enclosed volume. The reservoir has an uncompressedstate and a compressed state. The walls of the reservoir are movablewith respect to each other, such that moving the walls expresses thevolume adjustment limit of the reservoir. The walls can be operablyconnected by movable structures configured such that two adjacent wallsare configured to rotate around substantially orthogonal axes withrespect to each other when the reservoir moves from an uncompressed to acompressed state. In some embodiments, the movable structures can behinges, such as snap-fit assembly hinges. The movable structures and themovable walls can be co-molded together. In some aspects, the device caninclude a covering layer of the body of the reservoir. The coveringlayer can be a slide-on skin, and/or comolded or adhered to the walls ofthe reservoir.

In some embodiments, the device is configured such that applying a forceto at least one of the walls of the device will result in the reservoirmoving from the uncompressed state to a fully compressed state. Thedevice can also be configured such that an expressed volume of thedevice for a given adjustment limit is consistently no more than about10 cc of a disclosed volume setting on the volume adjuster fromcompression to compression for a given force of compression and airwayresistance of a patient. The device can also further include a volumerestoring mechanism to restore the reservoir from the compressed stateto said uncompressed state. The volume restoring mechanism can be, forexample, a compression spring, an extension spring, or a resilientcovering layer. The volume adjuster can include a stop dial.

In some aspects, the device can further include a frequency adjuster toadjust the time to restore the reservoir from the compressed state tothe uncompressed state, and/or the time to compress said reservoir fromthe uncompressed state to the compressed state. The device can beconfigured such that the maximum change in expressed volume of thereservoir is no more than about 1400 cc, no more than about 1200 cc, nomore than about 500 cc, or no more than about 250 cc in someembodiments. The device can include tactile feedback areas on one ormore of said walls. The tactile feedback areas can be flexible areas andsized and positioned to fit a thumb of a hand or one or more fingers ofthe hand. The device can also include a visual feedback mechanism. Insome embodiments, the visual feedback mechanism is an expandable airreservoir operably connected to the inlet mechanism of the device; theair reservoir having an expandable wall configured to indicate thepresence of air flow through the reservoir. In some embodiments, thedevice further includes an audible feedback mechanism, which is apop-off valve in some embodiments.

The device can also include an air filter operably connected to theinlet of the device. Furthermore, the device can also include an inflowline with measurement markings to measure an aspect of the patient andestimate an appropriate expressed volume based on the measurement. Insome aspects, the device can be compressed in a stored configuration toless than 35% of a fully expanded volume of the device; wherein thedevice is configured to deliver at least 95% of the fully expandedvolume of the device after being stored for at least about 3 years, 5years, 10 years, 15 years, or more. The device can also be configuredsuch that three devices can be stacked in a shelf with a shelf height ofno more than about 200 mm, or no more than about 180 mm. The device canalso have a height of no more than about 70 mm and/or a side panel widthof no more than about 50 mm to allow the device to be comfortablycompressed in one hand by an operator.

In some aspects, also disclosed is a method of ventilating a patient.The method includes the step of providing a ventilation device thatincludes a reservoir with an inlet mechanism, an outlet mechanism, and avolume adjuster configured to move a volume adjustment limit of thereservoir and change an expressed maximum volume of the reservoir. Thereservoir can include a body having a plurality of movable wallsdefining an enclosed volume. The reservoir has an uncompressed state anda compressed state. The walls can be movable with respect to each other,such that moving the walls expresses the volume adjustment limit of thereservoir. The walls can be operably connected by movable structuresconfigured such that two adjacent walls are configured to rotate aroundsubstantially orthogonal axes with respect to each other when thereservoir moves from an uncompressed to a compressed state. The methodalso can include the step of selecting an appropriate expressed maximumvolume setting from the volume adjuster. In some aspects, the device isconnected the inlet of the device to an air or oxygen source. Also, theoutlet of the device can be connected to a mask or tube configured tointerface with a patient's airway. Next, the device can be actuated froman uncompressed state to a compressed state by applying a force to atleast one wall of the device. In some aspects, the method includes thestep of releasing the force to allow the reservoir to move back from thecompressed state to the uncompressed state. The reservoir can moves backfrom the compressed state to the uncompressed state by the action of avolume restoring mechanism. As noted above, the volume restoringmechanism can be, for example, a compression spring, an extensionspring, and a resilient covering layer. The movable structures can behinges. The movable structures and the walls can be co-molded together.The device can be configured such that the maximum change in expressedvolume of the reservoir is no more than about 1400 cc.

In some embodiments, selecting an appropriate expressed maximum volumesetting from the volume adjuster involves turning a stop dial. In someaspects, the method includes the step of adjusting the time to restorethe reservoir from the compressed state to the uncompressed state oradjusting the time to compress the reservoir from the uncompressed stateto the compressed state. In some aspects, the method also includes thestep of observing a visual feedback mechanism that indicates thepresence of airflow into the device. The visual feedback mechanism canbe, for example, an air reservoir with an expandable wall configured toindicate the presence of air flow through the reservoir. In otheraspects, the method includes the step of listening to an audiblefeedback mechanism that provides feedback over one or more of the groupconsisting of: the compression speed, frequency, and expressed volume ofthe device. Also, the method can include the step of filtering airbefore air enters the body of the device.

Also disclosed is a face mask for use with a manually operablevolume-adjustable ventilation device. The mask includes an inlet, aninner portion operably connected to the inlet, and an outer portion. Themask can be configured to transform from a first configuration to fitover an adult's face to a second configuration to fit over a child'sface. The mask can also be configured to reversibly transform from afirst configuration to fit over an adult's face to a secondconfiguration to fit over a child's face. The inner portion can includea bi-stable cone movable between a first stable position to a secondstable position. The mask can also include a tear-away seam between theinner portion and the outer portion.

In other embodiments, also disclosed is a face mask for use with amanually operable volume-adjustable ventilation device; the maskconfigured to create a sealing surface on a patient's face, the sealingsurface extending substantially from cephalad at the base of the nosenear the alar sidewalls to caudally under the mandible.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a three-dimensional perspective view of a manualventilation device, according to one embodiment of the invention.

FIGS. 1A-C are schematic diagrams illustrating movement of panels of amanual ventilation device in the presence and absence of movablestructures, according to one embodiment of the invention.

FIG. 2 shows a side view of the device of FIG. 1, according to oneembodiment of the invention.

FIG. 3 shows a top view of the device of FIG. 1, according to oneembodiment of the present invention.

FIG. 4 shows a front view of the body of the device of FIG. 1, accordingto one embodiment of the invention. The hook-up to a mask or intubationtube, and outlet is left out for clarity.

FIG. 5 shows a hand with dimensions for grasping and operating thedevice according to one embodiment of the invention.

FIG. 6 shows an exploded view of the device of FIG. 1, according to oneembodiment of the invention.

FIG. 7 shows an example of a size (volume) adjuster of the deviceaccording to one embodiment of the invention.

FIG. 7A illustrates an exploded perspective cut-away view of anadjustment dial, according to one embodiment of the invention.

FIG. 7B illustrates a horizontal sectional view of an adjustment dial,according to one embodiment of the invention.

FIG. 8 shows an example of a mechanism to restore the volume of the bodyof the device from a compressed state to an uncompressed state accordingto some embodiments of the invention.

FIG. 9 shows an example of a frequency adjuster of the device accordingto one embodiment of the present invention.

FIG. 10 shows an example of a visual feedback mechanism according to oneembodiment of the present invention.

FIG. 11 shows an example of a tactile feedback mechanism according toone embodiment of the present invention.

FIG. 12 shows an example of stacking or nesting devices according to oneembodiment of the present invention.

FIGS. 13A-D illustrate embodiments of visual airflow indicators that canbe used with a volume-adjustable manual ventilation device, according tosome embodiments of the invention.

FIG. 14 illustrates an inflow line configured to allow for measuring anaspect of the patient, according to one embodiment of the invention.

FIG. 15 is a perspective view of a ventilation device, according to oneembodiment of the invention.

FIG. 16 is an exploded view of the ventilation device illustrated inFIG. 15.

FIG. 17A is a side view of the ventilation device of FIG. 15 in anuncompressed state, with the covering layer removed for clarity.

FIG. 17B is a side view of the ventilation device of FIG. 15 in acompressed state.

FIGS. 18A-B are top horizontal sectional views of the ventilation deviceof FIG. 15 in uncompressed and compressed states, respectively.

FIG. 19A is a vertical sectional view of device 1500 through line19A-19A of FIG. 18A.

FIG. 19B is a vertical sectional view of device 1500 through line19B-19B of FIG. 18B.

FIGS. 20A-D illustrate a face mask that includes a bi-stable cone suchthat the mask can be reversibly transformed from a first configurationfor adults to a second configuration for pediatric patients, accordingto one embodiment of the invention.

FIGS. 21A-C illustrate a face mask with a tear-away seam such that themask can be transformed from a first configuration for adults to asecond configuration for pediatric patients, according to one embodimentof the invention.

FIGS. 22A-C illustrate an embodiment of a face mask that is shaped andconfigured to create a sealing surface extending from cephalad at thebase of the nose near the alar sidewalls to caudally under the mandibleas shown.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Although the following detailed description contains many specifics forthe purposes of illustration, one of ordinary skill in the art willreadily appreciate that many variations and alterations to the followingexemplary details are within the scope of the invention. Accordingly,the following preferred embodiments of the invention are set forthwithout any loss of generality to, and without imposing limitationsupon, the claimed invention.

A three-dimensional view of one example of the ventilation orresuscitation device 100 is shown in FIG. 1. In general, three parts canbe distinguished: a reservoir that includes a body 110, an inputmechanism 120 to allow input of e.g., air, oxygen, oxygen-enriched air,fluid, fluid mixture, gas, gas mixtures or any combination or derivativethereof in body 110, and an output mechanism 130 to output and deliversome or all of the inputted content from body 110 to an individual viaconnector 132. Body 110 distinguishes a plurality of movable walls (alsoreferred to as panels herein). Movable walls can be, in someembodiments, panels that are movable with respect to each other. In someembodiments, the panels are rigid or substantially rigid. Design of body110 with rigid panels encompasses a sealed volume that can contain e.g.,air, oxygen or oxygen-enriched air. Another aspect of the invention isto be able to hold the body of the device with one hand and to compressthe body with that one hand. In one embodiment, as will be clear fromreading the description, disclosed is a device with a body having rigidpanels whereby the body is characterized as having a displacement in adirection of a hand displacement and at least one other direction otherthan that particular hand displacement.

In the particular example of FIG. 1 body 110 distinguishes a pluralityof panels; e.g., panels forming the top, panels forming the bottom, andpanels for each side. More particularly, the following (main) panels canbe distinguished, i.e. panels 140A, 140B, 140D, 140E, 140F, 140G and140H, which are all visible in FIG. 1; panels 140D, 140E, 140F, 140G,140H, 140D′, 140E′, 140F′, 140G′, 140H′, which are all visible in FIG.2; panels 140A, 140B, 140C, 140D, 140E, 140F, 140G, 140H, 140D″, 140E″,140F″, 140G″ and 140H″, which are all visible in FIG. 3; and panels 140Cand 140C′, which are all visible in FIG. 4. Panels blocked from theviews in FIGS. 1-4, are 140A′, 140B′, 140D′″, 140E′″, 140F′″, 140G′″,140H′″. The relative positions and orientations of the panels blocked inthe figures is readily appreciated by a person of ordinary skill in theart to which this invention pertains.

The movable parts or structures, indicated by 150 in FIGS. 1, 2 and 4could be living joints/hinges, snaps, joints, fabricated flexures,heat-shrinked joints or flexures, welded joints, simple mechanicalhinges, pinned hinges, flexible hinges, snap-fit assembly hinges, or thelike. The type of movable structure 150 depends on the type ofmanufacturing that is used to create the rigid panels and body. Examplesof different types of manufacturing of the panels, movable structuresand body are e.g., blow molding, heat sealing, overmolding, themechanical assembly of a rigid paneled chassis with a flexible bladderor skin to form the body, coining to form living hinges, assembly usinggaskets as seals in hinges, injection molding, ultrasonic welding, radiofrequency welding, dielectric welding, high frequency welding, dipping,extrusion, spray coating, brush on, assembly of adhesive backed sheetsof various materials, and/or any type of manufacturing that results in abody with rigid panels that are movable with respect to each other. Insome embodiments, the panels of the body 110 and the movable structures150 are co-molded together to allow for the use of a very compliant lowdurometer material for the panels of the device 100 to advantageouslyprovide a soft grip for an operator of the device, while still utilizinga very durable, rigid material for the movable structures 150. A personof ordinary skill in the art to which this invention pertains wouldreadily appreciate the different types of manufacturing that can be usedto make body 110, which are known techniques in the mechanical anddesign engineering art. Input mechanism 120 and output mechanism 130could be manufactured and integrated along with the manufacturingprocess of body 110 or later assembled to body 110. The types ofmaterials that can be used for the rigid panels, input mechanism 120,output mechanism 130 and other structures of the device are, forexample, polymers, plastic, polyethylene, polycarbonate, high impactpolystyrene, K-resin, ABS, PVC, acetal, polypropylene, silicone,thermoplastic elastomers, thermoplastic rubbers, latex, fabrics,cardboard, or the like.

The volume delivery is preferably consistent from compression tocompression, as well as consistent with respect to a disclosed volumesetting on the volume adjuster. In a preferred embodiment, the device100 is configured to output a consistent, reproducible volume for agiven speed of compression of the device 100 by an operator and for agiven airway resistance. In some embodiments, the actual volumedelivered differs by no more than about 50 cc, 40 cc, 30 cc, 25 cc, 20cc, 15 cc, 10 cc, 5 cc, or less than the volume selected on the volumeadjuster to be delivered. In some embodiments, the device 100 can beconfigured such that the actual volume delivered per compression can beconsistently reproducible within no more than about 50 cc, 40 cc, 30 cc,25 cc, 20 cc, 15 cc, 10 cc, 5 cc, or less from a preset delivered value(e.g., from volume adjuster) compression to compression.

The device 100 is also preferably configured to preferably deliver aconsistent volume regardless of the manner or speed in which the deviceis compressed. In some embodiments, the device 100 is configured todeliver a consistent volume when compressed using a mechanical force,for example, one hand, two hands, one foot, two feet, a knee, in betweentwo knees, an elbow, or a forearm (while bracing the device against athigh or other surface, e.g., a table or the patient's head). The device100 is also preferably configured such that applying a force to any oneor more of the walls of the body 110 will result in delivery of aconsistent volume, and will also result in the device achieving a fullycompressed state. The fully compressed state of the device 100preferably has a volume of no more than about 40%, 35%, 30%, 25%, 20%,15%, 10% or less of the uncompressed state of the device 100.

Body 110 has an uncompressed state where the panels are positioned tocreate a volume that can be filled with e.g., air, oxygen oroxygen-enriched air. From the uncompressed state, body 110 can change toa compressed state where the panels are moved with respect to each otherto decrease the volume with respect to the volume in the uncompressedstate. In other words, moving the rigid panels with respect to eachother from the uncompressed state to the compressed state, air, oxygenor oxygen-enriched air is outputted via output mechanism 130. Theuncompressed state could be at full expansion (i.e. maximum volume) orany intermediate state (See also size adjuster (volume) description).Restoring the volume allows entry of new air, oxygen or oxygen-enrichedair into the volume via input mechanism 120.

In some embodiments, the device 100 also includes an air filter. The airfilter is preferably integrated with the device, for example, via anadapter operably connected to the input mechanism 120. The air filtercan advantageously remove dust, pollen, mold, bacteria, viruses, andother airborne particles from an air source prior to entry into body 110of the device 100. In some embodiments, the air filter is configured tomeet or exceed HEPA (high efficiency particulate air) filter standards.

Body 110 has a height H, width W and length L (see FIGS. 1-4). Ingeneral, the state changes of body 110 could be characterized by theheight H of body 110 being larger in the uncompressed state compared tothe compressed state. The height changes cause changes in width W andlength L, which are smaller in the uncompressed state compared to thecompressed state. The width and length changes are a function of theheight changes and the geometry of panels as a person of ordinary skillwould readily appreciate. It is further noted that the body could becharacterized by having at least two of the panels capable of rotatingaround substantially orthogonal axes with respect to each other;consider e.g., panels 140F and 140C which are both involved in theheight changes, but given their orientation, 140F is further related tothe width changes, and 140C is further related to the length changes. Insummary, the body is characterized as having a displacement in adirection of a “hand displacement (e.g., height of body) and at leasttwo other directions (e.g., width and length of body) other than theparticular hand displacement (e.g., height of body).

FIGS. 1A-1C are schematic diagrams illustrating the interaction ofpanels 140 where movable structures 150 are either present or absent ona ventilation device 100. FIG. 1A shows that adjacent movable walls(e.g., 140F and 140F′; 140F″ and 140F′″ are not shown) can be operablyconnected by movable structures 150, which can be snap-fit assemblyhinges, according to one embodiment of the invention. Dotted line 151represents an axis, defined by the border between two adjacent walls140F, 140F′ as shown, around which walls 140F and 140F′ can rotate withrespect to hinge 150. The movable structures 150 are preferablyconfigured such that a movable structure 150 operably connected to twoadjacent walls can rotate substantially uniformly around the axis 151when the reservoir 110 of device 100 moves from an uncompressed to acompressed state, and vice versa. In this way, the hinges 150 operablyconnected to adjacent walls, e.g., 140F, 140F′ advantageously providefor generally uniform collapse and expansion of the device 100substantially preventing non-uniform bending or sliding of the walls140F, 140F′ in axes other than axis 151 as shown; preventing non-uniformbending of walls 140A and 140C as shown, and resulting in consistentvolume delivery to a patient. This is in contrast to a ventilationdevice that collapses non-uniformly due to the absence of stabilizingmovable structures (such as hinges 150) between, for example, unhingedfolds of inflatable bladders, disclosed, for example in U.S. Pat. No.4,898,167 to Pierce et al., which is hereby incorporated by reference inits entirety. The absence of stabilizing movable structures (such ashinges 150) can result in rotation and/or flexing of the folds inmultiple axes, and consequently, inconsistent volume delivery. The sideview schematics shown in FIGS. 1B-1C illustrate how device 100 wouldnon-uniformly rotate without hinges 150 operably connected to panels140F and 140F′. FIG. 1B is a side view schematic of the device of FIG.1A depicting panels 140A, 140C, 140F, 140F′ without hinges 150. FIG. 1Cis of the same side view as FIG. 1B after compression of the device. Asshown, the absence of movable structures between, for example, panels140F and 140F′ can allow panels to rotate non-uniformly in multiple axesother than 151. End panel 140A, for example, could rotate non-uniformlywith respect to panel 140C. As noted above, this can undesirably lead toinconsistent volume delivery.

The body could also have a higher or a smaller number of panels thanbody 110, as a person of average skill in the art to which thisinvention pertains would appreciate. For example, the panels could beassembled radially around central top and bottom panels and more panelscan be added, for example, 140F can be broken up into two or morepanels. An example of reducing panel numbers could be achieved byreducing 140A, 140B and 140C to only two panels. In the latter examplethe body would have height and width or length changes. In summary, suchbodies could be characterized as having a displacement in a direction ofa hand displacement (e.g., the height of body) and at least one otherdirection (e.g., the width or length of body) other than the particularhand displacement (e.g., the height of body).

As mentioned above, one of the key objectives of the invention is to beable to hold the device with one hand and to be able to compress thebody with that one hand. To meet the objective the height and widthchanges in uncompressed and compressed state are therefore constrainedsince they would need to fit: (i) the hand of a user and (ii) thegrasping (or squeezing) range of motion of the user.

Furthermore, the thumb and one or more fingers are desirably positionedon body 110 to create a mechanical advantage (i.e. a large moment armwith respect to the point of rotation) when compressing the body. Such amechanical advantage meets another objective of the invention, which isto reduce fatigue of the hand muscles and potentially also the armmuscles.

FIG. 5 shows hand 500 with thumb 502, one or more fingers 504 and web ofthe hand 506 between which body 110 is typically held. Given a varietyof hand sizes (e.g. male, female, large and small) in mind one coulddetermine a reasonable range of motion and a comfortable fit to theuser's hand that constrains the height and width dimensions of body nowhen moving between the uncompressed state and a compressed state. Themaximum height of the fully expanded device, in some embodiments is nomore than about 100 mm, preferably between about 45-70 mm with a sidepanel (e.g., panels other than 140B and 140B′ in some embodiments) widthof no more than about 60 mm, preferably between about 30-50 mm. Thesedimensions, for example, advantageously allow the device to becompressed in one hand comfortably by a wide range of both male andfemale operators of the device 100. In some embodiments, the height andwidth (displacement) changes of a single panel axially could be no morethan about 85 mm, preferably no more than about 20-25 mm and morepreferably no more than about 10-15 mm. The height changes wouldcorrespond to a hand displacement 520 in FIG. 5 and the width changeswould correspond to a hand displacement 510 in FIG. 5. A person ofaverage skill in the art to which this invention pertains would readilyappreciate that the geometry (dimensions and relative angles) of thepanels could be varied to meet the desired height and width(displacement) changes as well as the desired deliverable tidal volume.

The length changes of a single panel axially could also be no more thanabout 85 mm but is, in some embodiments, not constrained by handdimensions, but will be a variable in determining the change in volume.The change in enclosed volume of the device (in other words, thedeliverable or expressed volume of a device) is typically no more thanabout 1400 cc in some embodiments. In other embodiments, the deliverablevolume ranges from about 250 to 1200 cc, which covers tidal volumeranges for children and adults. When the device is used for infant orchild purposes the volume changes are smaller and preferably are no morethan about 500 cc. The maximum deliverable volume of a device can, insome embodiments, be adjusted in increments of at least about 25 cc, 50cc, 75 cc, 100 cc, 125 cc, 150 cc, 200 cc, or more. The ability toconfigure the device to set an adjustable maximum deliverable tidalvolume advantageously provides an increased level of safety and reducesthe risk of excess volume delivery, and thus complications of volutraumasuch as pneumothorax.

FIG. 6 shows an exploded view of an embodiment of a ventilation device.In addition to the elements discussed above, the device further includesa main shaft 610 connected to output mechanism 130 and positioned insidebody 110. Main shaft 610 has narrow (cylindrical) end 612 and a slot614. The device further has a receiving shaft 620 connected (or could bea single part) to input mechanism 630 and also positioned inside body110. Receiving shaft 620 has an opening (not visible in figure) sized toallow travel of main shaft 610 along the length of receiving shaft 620.It further has a slot 622 preferably of equal size as slot 614; slots614 and 622 should also be aligned with each other as will be understoodwhen discussing volume recovery from compressed state to uncompressedstate with respect to FIG. 8. Opening 630 could be sized such thatelement 660 could be mechanically assembled by ultrasonic welding, snapfit, press fit, adhesive or any other known techniques in the mechanicaland design engineering art. Element 660 allows fitting and attachment ofair/oxygen input devices. A flutter valve 640 is fitted to the frontopening of element 660 allowing e.g. air travel into receiving shaft 620through opening 650 and then into body 110. Element 660 further houses asize adjuster (also referred to as volume adjuster).

In general, the size adjuster of the device adjusts the length changes,width changes and/or height changes. The size adjuster serves thepurpose of easily adjusting the deliverable volume so that the user canrely of a fairly constant volume of deliverable e.g. air, oxygen oroxygen-enriched air. Adjusting the deliverable volume is important tocompensate for factors such as physical condition, body size, age, sex,etc.

In a preferred embodiment, size adjuster is integrated with inputmechanism 120, in particular with element 660, and adjusts the travellength of body 110. The size adjuster distinguishes an adjustment knob160 placed on top of element 660 and conveniently accessible to a user.The adjustment knob 160 is connected to an adjustment dial 162, which inthis example is positioned inside element 660; the connection could e.g.be through either valve 670 or 680.

FIG. 7 shows adjustment dial 162 with a number of slots 710,712,714,716and 718. These slots are sized to fit narrow (cylindrical) end 612 ofmain shaft 610 that is able to travel all the way through the opening ofreceiving shaft 620 (as well as through flutter valve 640; not shown infigure) when moving between uncompressed and compressed states. Bychanging adjustment knob 160, adjustment dial 162 is rotated aroundpivot 720 to a new slot position; this is typically done when the bodyis in compressed state. It is noted that size adjuster changes thedimension of the uncompressed state or volume.

Slots restrict the travel distance of main shaft 610 and therewithcontrol the deliverable volume to an individual. Slot sizes could be upto no more than about 170 mm to allow changes in length, and preferablyare no more than about 25 mm. The number of slots and the sizes of theslots are selected to cover a reasonable range of deliverable tidalvolumes as a person of ordinary skill in the art will appreciate.

In the example of FIG. 7, the size (length) (volume) adjuster is placedoutside body 110. A person of average skill in the art to which thisinvention pertains would appreciate that the size adjuster can also bepositioned inside the body or intrinsic to the design of the body.Furthermore, the size adjuster could also be added for width or heightcontrol or any combination of height, length or width, or any otherdirection in a similar fashion as shown in FIG. 7.

FIG. 7A illustrates an exploded perspective cut-away view of anotheradjustment dial 163, according to one embodiment of the invention. Shownare the variable-length slots 750, 752, 754, 756, 758 that areconfigured to fit the narrow end 1612 of a slider-type volume adjuster,such as 1610 of FIG. 16 (shown in FIG. 7A not necessarily to scale).Narrow end 1612 can be rectangular, although other shapes can also beused as known in the art. Turning the adjustment dial 162 in anappropriate direction will thus change the travel distance of main shaftof slider 1610 within the body 110 of device 100, and thus control thetidal volume delivered to an individual as noted above. In someembodiments, the slots 750, 752, 754, 756, 758 are configured such thatturning the adjustment dial 163 to allow end 1612 of slider 1610 toengage an adjacent slot will produce a change in deliverable tidalvolume of at least about 25 cc, 50 cc, 75 cc, 100 cc, 125 cc, 150 cc,200 cc, or more. In some embodiments, a label (not shown) is present onor near adjustment dial 163 to assist an operator by indicating, forexample, the numerical tidal volume correlating to the appropriate slot,and/or whether the slot setting is appropriate for adults, children, orinfants. FIG. 7B is a horizontal sectional view of an adjustment dial163 with slots 750, 750′, 752, 752′, 754, 754′, 756, 756′, 758, 758′ inwhich slots spaced 180 degrees apart, such as slots 750, 750′ have thesame or substantially the same length to accommodate end 1612 of slider1610.

Instead of a size adjuster with slots, one could design and integratedifferent types of mechanisms, which are all within the scope of thepresent invention. Examples of such variations are e.g. an adjustablethreaded stop for the main shaft, an element with chambers whereby eachchamber has grooves or each chamber has different depths, a slotted tubewith different positions of the slots to set travel constraints to themain shaft, deflecting stops that deflect when adjusted in an incorrector uncompressed state, a rack and pinion system with stops, ratchetingband (adjustable zip-tie), adjustable cam, a rotating dial of springloaded stops that deflect when adjusted in an incorrect or uncompressedstate, or any type of engineering mechanism that constrains the travelof the main shaft to control the volume output.

FIG. 8 shows an example of a volume restoring mechanism to restore thevolume from a compressed state back to the uncompressed state. Thiscould be accomplished by main shaft 610 traveling inside receiving shaft620 whereby (part of) slots 614 and 622 travel inline with each other.One site of slot 614 is connected to an opposite site of slot 622 byelement 810, which is e.g. an extension spring, plastic or rubber. Whenwe change from uncompressed state to compressed state, force is built-upin element 810. This force is then used to restore the body back to theuncompressed state when the user releases the compression force appliedto body 110. As a person of average skill in the art to which thisinvention pertains would appreciate, the volume restoring mechanismcould also be outside body 110 or intrinsic to body 110 (e.g. one couldhave the restoring force as an intrinsic property of the movable joints150). Other alternatives are a leaf spring mechanism inside body 110that builds up force when compressed or an extension spring/mechanismplaced inside body 110 but not integrated with the two shafts. Thevolume restoring mechanism could be adjusted using similar techniques asdiscussed for the size (volume) adjuster or it could be left to onesetting.

In an alternate embodiment, the device includes a frequency adjuster toset and control the time to: (i) restore the volume from a compressedstate back to the uncompressed state, and/or (ii) compress the volumefrom uncompressed state to a compressed state. The volume restoringmechanism as discussed above could be used as a frequencyadjuster/controller. However, in this scenario, the frequency control isthen still in hand of the user and not constrained by the device.Control over frequency is desired to enforce consistency in tidal volumerate. Therefore in another embodiment a frequency adjuster is added in asimilar fashion as the size adjuster.

A frequency control knob could be placed at the opposite site of element660 and implemented to adjust the frequency by e.g. a rack and pinionmechanism in combination with the main shaft to set the dampening oftravel of the main shaft, a rack and pinion mechanism coupled withrotationally resistant gears, a polymer escapement mechanism, a frictionbrake, a rotationally resistant ratchet wheel, or a track to deflect thetravel of the main shaft. All such mechanisms, which are known in themechanical and design engineering art, can be adjusted via a frequencycontrol knob to change the dampening of the travel of the main shaft,whereby an increase in dampening would result in a decrease infrequency. Similarly to the size adjuster mechanism, the frequencyadjuster could also be inside the body, outside the body or intrinsic tobody.

FIG. 9 shows an example of an embodiment of a frequency controlmechanism 900 that is accomplished by a ratchet mechanism 910 placed onfrequency control knob 920. Frequency control knob 920 can extend upfrom an identical knob to volume control knob 610, inverted andassembled to the bottom of the element 660. A ratchet wheel 930 can beassembled to frequency control knob 920 by e.g. a snap fit, a fasteneror any other means. Frequency control knob 920 can be rotated withratchet wheel 930 in line with the main rod's travel or outside of itstravel. The ratchet wheel's rotation can be dampened by multiple methodssuch as e.g. a friction insert, a roll pin, a coil or a watch spring, ahigh friction disc, or the like. There could be a variety of ratchetwheels along the circumference of frequency control knob 920 to adjustthe resistance to main rod 610 depending on the rotation direction offrequency control knob 920. In some embodiments, the frequency controlmechanism 900 can be configured such that the device can deliver no morethan about 40 breaths per minute. In some embodiments, frequency controlmechanism 900 can be configured to adjust frequency in increments of nomore than about 10, 8, 6, 5, 4, 3, 2, or 1 breaths per minute.

A visual feedback mechanism could be added to provide the user withvisual feedback (colors, markings, symbols, or the like) on theadjustments to size, travel of the main shaft, or the frequency. FIG. 10shows an example of a visual feedback mechanism for the size (volume)adjustments. Main shaft 610 could travel across a ruler 1010 designed toindicate e.g. minimum min, average avg, and maximum max deliverabletidal volume (expressed volume). The relative position of narrow end 612of main shaft 610 to markings 1012 could further assist in fine-tuningthe desired volume. The visual feedback mechanism could be placed insidea body whereby the body has a transparent part allowing a user tovisualize the visual feedback mechanism. A similar feedback mechanismcould be applied for the frequency.

One could further add an audible feedback mechanism (beeps, timers,commands, warnings, or the like) that provides feedback over thecompression speed, frequency, tidal volume, setting of the size (volume)adjuster or setting of the frequency control adjuster. Another exampleis to have a click mechanism associated with the travel of the shaft(s)and/or changes in volume. The clicking sounds could also be used as atactile feedback; e.g. the clicks can be felt through the hand. In someembodiments, the audible feedback mechanism is a pop-off valve that canbe operably connected to output mechanism 130. The pop-off valve can beconfigured to provide an audible cue when a certain threshold airwayresistance is reached, thus alerting the operator of the device of apotential airway problem such as a foreign body, pneumothorax, orinadvertent gastric intubation.

In still another embodiment, one could add tactile feedback areas 1130on one or more of panels such as panel 140B as shown in FIG. 11; 1110 isa top view and 1120 is a side view. Tactile feedback areas 1130 aresized and positioned to fit a thumb of a hand or one or more fingers(e.g., on panel 140B′) of the hand. These areas are made of a flexiblematerial that is responsive to thumb or finger pressure as well aspressure from e.g. the air/oxygen inside the body. This will provide theuser additional feedback on the compression force and lung resistance.Deflection 1132 of flexible material 1130 with respect to the rigidpanel 140B illustrates the deflection caused by e.g. a finger duringcompression.

FIG. 12 shows an example of stacking or nesting multiple devices 100 ontop of each other. Stacking or nesting would be beneficial where spaceis limited, e.g. in an ambulance, and where multiple devices might berequired. In one example the design and geometry of the inlet mechanism,body and/or output mechanism allows them to nest with one another. Forexample, the top of the output mechanism could nest into the bottom ofanother output mechanism (a similar nesting could be established for theinput mechanism). Besides fitting the devices together, the device couldalso have features, e.g. ribs, indentations, Velcro, snap-mechanism, orthe like, that prevent side-to-side movement. In one embodiment, thebody 110 of the device 100 has dimensions of about 200-235 mm×240-290mm×50-65 mm in a compacted configuration. In some embodiments, threedevices can fit in a shelf height of no more than about 250 mm, 240 mm,230 mm, 220 mm, 210 mm, 200 mm, 190 mm, 180 mm, 170 mm, 160 mm, 150 mm,or less.

In some embodiments, device 100 can maintain its maximum fullyuncompressed volume, as well as deliver a consistent tidal (delivered)volume after being stored for a prolonged period of time. Being able tomaintain this capability can be highly advantageous over currentbag-type ventilators, for example, which have a relatively shortshelf-life due to degradation of the bag material over time.Furthermore, use of a compression spring as a volume restoringmechanism, for example, can be advantageous as relaxation of the springover time should not significantly affect the deliverable volume of thedevice. Volume delivery effected by creep or stress relaxation ofcomponents can be minimized by using an appropriate material as known inthe art, such as a polymer. In some embodiments, a device 100 can bestored for at least about 1 year, 2 years, 3 years, 4 years, 5 years, 7years, 10 years, 15 years, 20 years, 25 years, 30 years, or more whilemaintaining the capability to compress to a volume of less than about35%, 30%, 25%, 20%, 15%, 10%, or less of the fully uncompressed volumeof the device, as well as expand to at least about 90%, 95%, 97%, 98%,99% or more of the fully uncompressed volume of the device prior tostorage.

FIGS. 13A-D illustrate embodiments of visual airflow indicators that canbe used with a volume-adjustable manual ventilation device, according tosome embodiments of the invention. The visual airflow indicator providesa visual cue that air is flowing into the device 100 for delivery to apatient's airway. The visual airflow indicator can be operably connectedto the input mechanism 120 of the device 100. The visual airflowindicator can be, in some embodiments, an expandable reservoir as partof an inflow line 1300, for example, an oxygen line or reservoir tube,and can be integrally connected to input mechanism 120 itself. Thereservoir 1300 can be made of any appropriate material known in the art,such as, for example, a polymer, plastic, or rubber. FIGS. 13A-Billustrate one embodiment of a visual airflow indicator 1302, 1302′ thatis a circumferentially-expandable bag movable from a first deflatedconfiguration 1302 in the absence of airflow into the input mechanism120 (FIG. 13A) to a second inflated configuration 1302′ when air isflowing into the input mechanism 120 (FIG. 13B). FIGS. 13C-D illustrateanother embodiment of a visual airflow indicator 1300 that includesexpandable elements 1304 that can expand radially outwardly toconfiguration 1304′ as shown (FIG. 13D) when air is flowing into theinput mechanism 120.

FIG. 14 illustrates an inflow line 1400 (e.g., an oxygen line or areservoir tube) that may be operably connected to input mechanism 120 ofdevice 100 and configured to allow for measuring an aspect of thepatient, such as the patient's height. The patient's height, combinedwith knowledge of the patient's weight, or an estimation of their idealbody weight, can be used to calculate the patient's body mass index andselect an appropriate volume delivery setting using the volume adjusterof the device 100. In the embodiment shown, inflow line 1400 includesmarkings 1402 that can define, for example, length measurements ininches or centimeters. In other embodiments, inflow line 1400 includescolor-coded marking sections that correspond to colors on volumeadjuster, such as adjustment dial 162. Other markings or coding systemson various elements of the device configured to measure an aspect of thepatient to determine an appropriate volume (and/or frequency setting, toset an appropriate minute ventilation) can also be used, as will beappreciated by one of ordinary skill in the art.

FIG. 15 is a perspective view of a ventilation device 1500 similar tothe device 100 shown and described in connection with FIGS. 1-4. Body1510 of device 1500 is encompassed by a covering layer 1501 (as betterunderstood from FIG. 16) over panels 1540A, 1540B, 1540C, 1540F, 1540F″and movable structures 150 of the device 1500 (panels and movablestructures are more clearly seen in FIG. 16 below), and serves toprovide an air-tight seal over the body 1510 of the device 1500.Covering layer 1501 (also referred to as the skin) may be made ofplastic, rubber, polymer, thermoplastic elastomer, or other suitablematerial as would be appreciated by one of ordinary skill in the art.Covering Layer 1501 may be slid on, adhered, co-molded, radio frequencywelded, mechanically locked using rivets or screws, or otherwiseattached to the body 1510 as known in the art. Covering layer 1501 canalso advantageously act as a volume restoring mechanism if made of aresilient material, such as an elastomer.

Device 1500 also includes an input mechanism 1520 and output mechanism1530 to output and deliver some or all of inputted content from body1510 via patient connector 1533 as described in connection with FIG. 1above, as well as adjustment dial 163. Also shown is positiveend-expiratory pressure connector 1532 of output mechanism 1530 (“PEEP”connector). In contrast to the device 100 shown in FIGS. 1-4, device1500 does not include panels 140D, 140D′, 140D″, 140D′″, 140E, 140E′,140E″, 140E′″, 140G, 140G′, 140G″, 140G′″, 140H, 140H′, 140H″, and140H′″ of device 100.

FIG. 16 is an exploded view of the device 1500 illustrated in FIG. 15.Body 1510 of device 1500 includes first portion 1606 and second portion1608. First portion includes a plurality of panels 1540A, 1540B, 1540C,1540F, 1540F″ operably connected by movable structures 150 that arepreferably snap-fit hinges in some embodiments, as described inconnection with FIG. 1 above. First 1606 and second portions 1608 alsocan include apertures 1611 as shown configured to receive a screw, nail,bolt, snap-on nub, or the like to connect first 1606 and second portions1608 together and/or to the covering layer 1501. Also illustrated isoutput mechanism 1530 and patient connector 1533 as previouslydescribed, and attached to body 1510 via element 1531 which can be aseal, gasket, or the like. Input mechanism 1520 and adjustment dial 163can also be as previously described, and can be connected to body 1510via elements 1521 and 1561, respectively. Elements 1521, 1561 may beseals, gaskets, and the like similar to element 1531. Adjustment dial163 shown rotates in a plane perpendicular to main slider 1610 withnarrowed end 1612, although it can also rotate parallel, or in otherorientations to main slider 1610 as well in other embodiments. Asdescribed in connection with FIG. 7 above, other volume adjusters knownin the art may be used as well.

Second portion 1608 of body 1510 includes panels 1540A′, 1540B′, 1540C′,1540F′, and 1540F′″ also connected by movable structures 150. Alsoillustrated is main slider 1610 which can include elements of main shaft610 and receiving shaft 620 as described in connection with volumeadjuster and volume restoring mechanism and FIGS. 7-8 above. Main slider1610 movably resides within main slider housing 1602. Element 810 shownis a spring, preferably a compression spring as part of volume restoringmechanism as described in connection with FIG. 8 above.

Also shown in FIG. 16 are side sliders 1600 connected to panels 1540F,1540F′ and panels 1540F″, 1540F′″ by movable structures 150, e.g.,snap-fit hinges. Side sliders 1600 movably reside within side sliderhousing 1604, and structurally stabilize the device 1500 duringactuation, as better illustrated in FIGS. 17-18 below.

FIG. 17A is a side view of device 1500 in an uncompressed state withcovering layer 1501 removed for clarity. Shown are input mechanism 1520,output mechanism 1530 with patient connector 1533 and PEEP connector1532, and panels 1540A, 1540A′, 1540C, 1540C′, 1540F and 1540F′ operablyconnected to adjacent panels by hinges 150 as previously described. FIG.17B shows the device of FIG. 17A (with covering layer 1501) in acompressed state.

FIGS. 18A-B are top horizontal sectional views of device 1500 inuncompressed and compressed states, respectively. As shown (and perhapsbetter seen in FIGS. 19A-B), side sliders 1600 move medially toward eachother as the device 1500 moves from the uncompressed to the compressedstate, while narrow end 1612 within main slider 1610 moves into slot 750(and slot 750′, not shown) of adjustment dial 163. Exertion of acompressive force (e.g., by manual pressure on one or more panels) ondevice 1500 will result in a buildup of force within spring 810 (whichis preferably a compression spring in this embodiment) and result inrestoring the body 1510 back to an uncompressed state when thecompressive force is released.

FIG. 19A is a vertical sectional view of device 1500 through line19A-19A of FIG. 18A. FIG. 19B is a vertical sectional view of device1500 through line 19B-19B of FIG. 18B. Shown are panels 1540A, 1540A′,1540B, 1540B′, 1540C and 1540C′ operably connected to adjacent panels byhinges 150 as previously described. As noted above, as device 1500 movesfrom the uncompressed (FIG. 19A) to the compressed (FIG. 19B) state,narrow end 1612 of main slider 1610 will move into slot 750 (and slot750′, not shown) of adjustment dial 163. As will be readily appreciatedby one of ordinary skill in the art and described in connection withFIG. 7A above, tidal volume delivered by device 1500 can be readilyadjusted by actuating adjustment dial 163 in an appropriate direction,thus changing to a different slot with a different length and distancetraveled by main shaft 610 from the uncompressed to the compressedstate.

FIGS. 20A-D illustrate a face mask 2000 that can be used with aventilation device, according to one embodiment of the invention. Asingle face mask can advantageously be adapted for both adult andpediatric uses, obviating the need for two separate masks. As shown inFIG. 20A, face mask 2000 includes an outer portion 2004 and an innerportion 2002. The inner portion 2002 is most preferably a bi-stable coneconfigured to move from a first stable position 2002 to a second stableposition 2002′. In doing so, the bi-stable cone 2002 is displacedvertically, creating linear movement. In a preferred embodiment, thefirst stable position 2002 will allow the mask 2000 to generally fitover an adult airway while the second stable position 2002′ will allowthe mask 2000 to generally fit over a pediatric airway. The outerdiameter 2003 of cone 2002 is preferably substantially circular, oval,or the like, although other possible shapes for the outer diameter 2003can also be readily envisioned. The bi-stable cone also has an inletportion 2006 that may interface with, for example, an outlet of aventilator or an oxygen line, such as patient port 1533.

Face mask 2000 can be transformed from an first configuration for adultuse to a second configuration for pediatric use in the following manner.FIG. 20B illustrates a vertical sectional schematic view of face mask2000 positioned over an adult patient's face. Face mask 2000 is shownoperably connected at inlet portion 2006 to connector 132 of outlet 130of ventilation device 100. A first length 2010 of mask 2000 that spans alength over adult patient's face is shown. To transform the mask 2000for pediatric use, an operator can apply pressure to bi-stable cone 2000to move cone 2000 from first stable position 2002 (shown in phantom) tosecond stable position 2002′ as shown in FIG. 20C. Next, mask 2000 isturned over as shown in FIG. 20D. Once turned over, mask 2000 has asecond length 2008 that spans a length over pediatric patient's face asshown; second length 2008 is less than first length 2010. One ofordinary skill in the art will readily appreciate that the mask can alsoreadily be transformed from the pediatric configuration to the adultconfiguration by performing the steps illustrated in reverse.

FIGS. 21A-C depict another face mask that can be used with a ventilationdevice, according to one embodiment of the invention. As shown in FIG.21A, face mask 2100 includes outer portion 2102, inner portion 2104, andinlet 2106. Outer portion 2102 and inner portion 2104 are operablyconnected by seam 2108. Seam is preferably made of a tear-away materialconfigured to facilitate tearing of inner portion 2104 from outerportion 2102. In some embodiments, the seam 2108 has thinned walls orperforations to facilitate tearing. In other embodiments, seam 2108includes an adhesive material to facilitate tearing. Other tear-awaymaterials known in the art can also be utilized as well. FIG. 21Bdepicts mask 2100 situated on an adult patient. Face mask 2100 can betransformed from an adult configuration 2100 to a pediatricconfiguration 2100′ by separating (e.g., by pulling apart) outer portion2102 from inner portion 2104. Pediatric configuration 2100′ andseparated outer portion 2102 are shown in FIG. 21C. The masks describedin connection with FIGS. 21-22 can, for example, have a length of nomore than about 135 mm, preferably between about 115-135 mm, and a widthof no more than about 115 mm, preferably between about 100-115 mm in anadult configuration of some mask embodiments. A pediatric configurationcan, for example, have a length of no more than about 115 mm, preferablybetween about 75-115 mm, and a width of no more than about 100 mm,preferably between about 70-100 mm.

FIGS. 22A-C illustrate an embodiment of a face mask 2200 that is shapedand configured to create a sealing surface extending generally (neardotted line 2206) from cephalad at the base of the nose 2202 near thealar sidewalls to caudally under the mandible 2204 as shown.Conventional masks are generally configured to create a sealing surfacecephalad from the nasion to caudal on the mandible. Application of mask2200 can advantageously create an improved sealing surface overconventional masks, and thus improved ventilation of a patient,especially when combined with a jaw thrust maneuver as known in the art.In some embodiments, the head-tilt chin-lift maneuver, as known in theart, can be substituted for the jaw thrust maneuver. The jaw thrustmaneuver is typically performed on a supine patient by kneeling down atthe patient's head and grasping the posterior aspects of the mandiblewith the fingers of both hands (with the thumbs at the chin) and liftingup. When the mandible is displaced forward, it pulls the tongue forwardand prevents it from occluding the entrance to the trachea, helping toensure a patent airway. FIGS. 22B and 22C illustrate different schematicperspective views of mask 2200 on the patient. A jaw thrust can beperformed submandibularly by applying a force as shown by arrow 2210.

While the present invention has been described herein with respect tothe exemplary embodiments and the best mode for practicing theinvention, it will be apparent to one of ordinary skill in the art thatmany modifications, improvements and subcombinations of the variousembodiments, adaptations and variations can be made to the inventionwithout departing from the spirit and scope thereof. For all of theembodiments described above, the steps of the methods need not beperformed sequentially.

1. A manually operable volume-adjustable ventilation device, comprising:a reservoir with an inlet mechanism, an outlet mechanism, and a volumeadjuster configured to move a volume adjustment limit of the reservoirand change an expressed maximum volume of the reservoir; wherein saidreservoir comprises a body having a plurality of movable walls definingan enclosed volume; wherein said reservoir has an uncompressed state anda compressed state; wherein said walls are movable with respect to eachother, such that moving said walls expresses the volume adjustment limitof the reservoir; wherein said walls are operably connected by movablestructures; wherein a first wall and a second wall rotate about a firstaxis, and wherein a third wall rotates around a second axis wherein saidsecond axis is substantially orthogonal to said first axis when thereservoir moves from an uncompressed to a compressed state.
 2. Thedevice of claim 1, wherein the movable structures are hinges.
 3. Thedevice of claim 1, wherein the movable structures and the movable wallsare co-molded together.
 4. The device of claim 1, further comprising acovering layer over the body of the reservoir of the device.
 5. Thedevice of claim 4, wherein the covering layer is a slide-on skin.
 6. Thedevice of claim 4, wherein the covering layer is co-molded or adhered tothe walls.
 7. The device of claim 1, wherein the device is configuredsuch that applying a force to at least one of the walls of the reservoirwill result in the reservoir moving from the uncompressed state to afully compressed state.
 8. The device of claim 1, wherein the device isconfigured such that an expressed volume of the device for a givenadjustment limit is consistently no more than about 10 cc of a disclosedvolume setting on the volume adjuster from compression to compressionfor a given force of compression and airway resistance of a patient. 9.The device of claim 1, further comprising a volume restoring mechanismto restore said reservoir from said compressed state to saiduncompressed state.
 10. The device of claim 9, wherein the volumerestoring mechanism is selected from the group consisting of: acompression spring, an extension spring, and a resilient covering layer.11. The device of claim 1, wherein the volume adjuster comprises a stopdial.
 12. The device of claim 1, further comprising a frequency adjusterto adjust the time to restore said reservoir from said compressed stateto said uncompressed state.
 13. The device of claim 1, furthercomprising a frequency adjuster to adjust the time to compress saidreservoir from said uncompressed state to said compressed state.
 14. Thedevice of claim 1, wherein the device is configured such that themaximum change in said expressed volume of the reservoir is no more thanabout 1400 cc.
 15. The device of claim 1, wherein the device isconfigured such that the maximum change in said expressed volume of thereservoir is no more than about 250 cc.
 16. The device of claim 1,further comprising tactile feedback areas on one or more of said walls.17. The device of claim 16, wherein said tactile feedback areas areflexible areas and sized and positioned to fit a thumb of a hand or oneor more fingers of said hand.
 18. The device of claim 1, furthercomprising a visual feedback mechanism.
 19. The device of claim 18,wherein the visual feedback mechanism is an expandable air reservoiroperably connected to said inlet mechanism of said device; said airreservoir having an expandable wall configured to indicate the presenceof air flow through the reservoir.
 20. The device of claim 1, furthercomprising an audible feedback mechanism.
 21. The device of claim 20,wherein said audible feedback mechanism is a pop-off valve.
 22. Thedevice of claim 1, further comprising an air filter operably connectedto the inlet.
 23. The device of claim 1, further comprising an inflowline with measurement markings to measure an aspect of the patient andestimate an appropriate expressed volume based on the measurement. 24.The device of claim 1, wherein the device can be compressed in a storedconfiguration to less than 35% of a fully expanded volume of the device;wherein said device is configured to deliver at least 95% of the fullyexpanded volume of the device after being stored for at least about 3years.
 25. The device of claim 1, wherein a device is configured suchthat three devices can be stacked in a shelf with a shelf height of nomore than about 180 mm.
 26. The device of claim 1, wherein a device hasa height of no more than about 70 mm and a side panel width of no morethan about 50 mm to allow the device to be comfortably compressed in onehand by an operator.
 27. A medical system comprising: the ventilationdevice of claim 1; and a face mask.
 28. A method of ventilating apatient, comprising: providing a ventilation device comprising areservoir with an inlet mechanism, an outlet mechanism, and a volumeadjuster configured to move a volume adjustment limit of the reservoirand change an expressed maximum volume of the reservoir; wherein saidreservoir comprises a body having a plurality of movable walls definingan enclosed volume; wherein said reservoir has an uncompressed state anda compressed state; wherein said walls are movable with respect to eachother, such that moving said walls expresses the volume adjustment limitof the reservoir; wherein said walls are operably connected by movablestructures; wherein a first wall and a second wall rotate about a firstaxis, and wherein a third wall rotates around a second axis wherein saidsecond axis is substantially orthogonal to said first axis when thereservoir moves from an uncompressed to a compressed state; connectingthe inlet of the device to an air or oxygen source; connecting theoutlet of the device to a mask or tube configured to interface with apatient's airway; and actuating the device from an uncompressed state toa compressed state by applying a force to at least one wall of thedevice.
 29. The method of claim 28, further comprising the step ofreleasing the force to allow the reservoir to move back from thecompressed state to the uncompressed state.
 30. The method of claim 29,wherein the reservoir moves back from the compressed state to theuncompressed state by the action of a volume restoring mechanism. 31.The method of claim 30, wherein the volume restoring mechanism isselected from the group consisting of: a compression spring, anextension spring, and a resilient covering layer.
 32. The method ofclaim 28, wherein the movable structures are hinges.
 33. The method ofclaim 28, wherein the movable structures and the walls are co-molded oradhered together.
 34. The method of claim 28, wherein the device isconfigured such that applying a force to at least one of the walls ofthe reservoir will result in the reservoir moving from the uncompressedstate to a fully compressed state.
 35. The method of claim 28, furthercomprising selecting an appropriate expressed maximum volume settingfrom the volume adjuster.
 36. The method of claim 28, further comprisingthe step of adjusting the time to restore said reservoir from saidcompressed state to said uncompressed state.
 37. The method of claim 28,further comprising the step of adjusting the time to compress saidreservoir from said uncompressed state to said compressed state.
 38. Themethod of claim 28, wherein the device is configured such that themaximum change in said expressed volume of the reservoir is no more thanabout 1400 cc.
 39. The method of claim 28, further comprising observinga visual feedback mechanism that indicates the presence of airflow intothe device.
 40. The method of claim 39, wherein the visual feedbackmechanism is an air reservoir with an expandable wall configured toindicate the presence of air flow through the reservoir.
 41. The methodof claim 28, further comprising the step of listening to an audiblefeedback mechanism that provides feedback over one or more of the groupconsisting of: the compression speed, frequency, and expressed volume ofthe device.
 42. The method of claim 28, further comprising the step offiltering air before air enters the body of the device.